Trial Information

Good or bad responders to preoperative radiochemotherapy for locally-advanced rectal
adenocarcinoma cannot be anticipated before pathological assessment of rectal specimen. The
purpose of this prospective monocentric study is to look for early seric biomarkers
predictive of tumor response (good and bad responders) in patients treated by preoperative
radiochemotherapy (45 Gy) for rectal adenocarcinoma using a proteomic approach. All patients
with locally-advanced rectal adenocarcinoma will be enrolled. Sequential samples of sera
will be collected before, during preoperative treatment and before surgery, and analysed
using a MALDI-TOF-TOF method. Proteomic analysis will be correlated to pathological response
in order to identify potential early biomarkers of tumor response.

Inclusion Criteria:

- T3T4 or N+ M0 rectal carcinoma

- histologically-proven adenocarcinoma

- from 0 to 15 cm from the anal verge

- patient is at least 18 years of age

- ECOG performance status = 2

- Patient and doctor have signed informed consent

Exclusion Criteria:

- Metastatic disease

- T1-T2 N0 rectal carcinoma

- Contra indication of radiotherapy or chemotherapy

- History of cancer

- Severe renal insufficiency

- Symptomatic cardiac or coronary insufficiency

- Patient included in a trial

- Previous radiotherapy or chemotherapy for this cancer

- No contraceptive treatment

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

differential expression of early seric biomarkers between good and bad responders.

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Location

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